ITN’s LEAP Study of Peanut Allergy Completes Enrollment of 640 Children

Enrollment phase completed one month ahead of schedule

May 8, 2009

Gideon Lack, Principal Investigator

The full cohort of 640 children has now been enrolled in the Immune Tolerance Network (ITN) LEAP study of peanut allergy. The study is being conducted under the direction of principal investigator Gideon Lack, MD at Evelina Children’s Hospital, part of Guys and St Thomas Hospital in London, UK. The study addresses a growing scientific and public health controversy as to whether children at risk of developing peanut allergy can best prevent the condition by regular consumption of peanut or by avoiding it altogether. Results of the long-term study are expected in 2013.

Peanut allergy has become a serious public health concern, as the incidence of the disease has doubled in the past decade. Public health authorities in the UK, and until recently in the US, currently recommend that children with eczema and/or egg allergies, or those whose parents suffer food allergies, avoid consuming peanut for the first few years of life. However, recent studies have shown that children in countries where peanut is regularly consumed during infancy have a lower incidence of peanut allergy. The LEAP Study was designed to address this contradiction.

The LEAP Study (short for “Learning Early about Peanut Allergy”) has enrolled infants 4-11 months old who are at high risk of developing peanut allergy  i.e. those with serious eczema and/or egg allergies. Each child is assigned to one of two groups: the first is asked to avoid all peanut until age 3, the second to consume 2g (approximately 1 tsp) of peanut protein three times per week until age 5. The children will be followed until reaching age 5, at which time the relative incidence of peanut allergy between the two groups will be compared.

Enrollment of the study began in December 2006, with an original goal of 480 subjects. Due to an overwhelmingly positive response from parents interested in the study, the enrollment rate was higher than expected. This allowed the investigators to extend the size of the study group to 640 children in order to increase the statistical power.

The LEAP study is being conducted by the Immune Tolerance Network and is sponsored by the National Institute of Allergy and Infectious Diseases, King’s College London and the Food Allergy Initiative.

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